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Vo Nederlandse praktijkrichtlijn
NPR-CEN/TR 15278 (en)
Workplace exposure - Strategy for the evaluation of dermal exposure
ICS 13.100
april 2006
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NPR-CEN/TR 15278
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Als Nederlandse praktijkrichtlijn is aanvaard: - CEN/TR 15278:2006,IDT
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TECHNICAL REPORT
CEN/TR 15278
RAPPORT TECHNIQUE TECHNISCHER BERICHT
March 2006
ICS 13.100
English Version
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Workplace exposure - Strategy for the evaluation of dermal exposure
Exposition sur les lieux de travail - Stratégie pour l'évaluation de l'exposition dermique
Exposition am Arbeitsplatz - Strategie zur Beurteilung der Hautbelastung
This Technical Report was approved by CEN on 20 September 2005. It has been drawn up by the Technical Committee CEN/TC 137.
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CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36
© 2006 CEN
All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.
B-1050 Brussels
Ref. No. CEN/TR 15278:2006: E
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CEN/TR 15278:2006 (E)
Contents
Page
Foreword..............................................................................................................................................................3 Introduction .........................................................................................................................................................4 Scope ......................................................................................................................................................5
2
Terms and definitions ...........................................................................................................................5
3
Assessment of dermal exposure .........................................................................................................7
4
Control ..................................................................................................................................................11
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Annex A (informative) The conceptual model ..............................................................................................12 Annex B (informative) Estimation and Assessment of Substance Exposure (EASE)..............................14 Annex C (informative) DeRmal Exposure Assessment Method (DREAM).................................................16 Annex D (informative) Determinants of dermal exposure ...........................................................................18
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Bibliography ......................................................................................................................................................20
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CEN/TR 15278:2006 (E)
Foreword This Technical Report (CEN/TR 15278:2006) has been prepared by Technical Committee CEN/TC 137 “Assessment of workplace exposure to chemical and biological agents”, the secretariat of which is held by DIN.
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Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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CEN/TR 15278:2006 (E)
Introduction Dermal exposure assessment explores the dynamic interaction between environmental contaminants and the skin. In contrast to inhalation exposure assessment, the assessment of dermal exposure remained a nascent field of scientific research and applied occupational hygiene for most of the twentieth century, although multiple fatalities and occupational skin diseases due to dermal exposure have been described in literature.
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During the last decade, dermal exposure has received more attention, and one of the important results was the development of a conceptual model for dermal exposure (see [1]). The model systematically describes the transport of contaminant mass from exposure sources to the surface of the skin. The model provides a structure for evaluating dermal exposure both qualitatively and quantitatively. The purpose of evaluating dermal exposure can differ substantially, as exposure analysis (to give guidance to control), risk assessment, and evaluation of exposure control can all be objectives to undertake assessments. In order to give guidance and to harmonise basic concepts and actions a strategy for evaluation of dermal exposure is proposed.
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CEN/TR 15278:2006 (E)
1
Scope
This Technical Report gives guidance on approaches for awareness and evaluation of dermal exposure in workplaces.
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This Technical Report describes strategies to evaluate exposure of the skin to chemical and biological agents qualitatively and quantitatively, e.g. to analyse exposure, as part of the risk assessment process, to investigate associations between exposure and diseases, and to evaluate control measures. The definitions and procedures given in this document are primarily related to dermal exposure to chemical substances. The specifications given in this Technical Report are not applicable to microbiological skin contaminants.
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Terms and definitions
For the purposes of this Technical Report, the following terms and definitions apply.
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NOTE The definitions are based on the implementation of exposure terminology by IPCS (see [2]) and the conceptual model (see [1]), see also Annex A.
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Adapted from EN 1540.
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NOTE
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2.1 agent any chemical or biological entity on its own or admixed as it occurs in the natural state or as produced by any work activity, whether or not produced intentionally and whether or not placed on the market
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2.2 dermal contact volume volume containing the mass of the agent that contacts the exposure surface NOTE 1
The dermal contact volume is given in litres (l).
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NOTE 2 The dermal contact volume is equivalent to the volume of the skin contaminant layer, and for practical reasons it is defined by the mass in kilograms (kg) of all substances contained in this compartment.
2.3 dermal exposure process of contact between an agent and human skin at an exposure surface over an exposure period 2.4 dermal exposure concentration exposure mass divided by the dermal contact volume or the exposure mass divided by the mass contained in the skin contaminant layer NOTE The dermal exposure concentration is expressed in grams per liter (g/l) or grams per kilogram (g/kg) respectively.
2.5 dermal exposure loading exposure mass divided by the exposure surface NOTE For practical reasons it can be expressed as the time-averaged mass divided by area-averaged skin 2 contaminant layer surface area in grams per square centimetre (g/cm ).
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CEN/TR 15278:2006 (E)
2.6 dermal exposure mass mass of agent present in the dermal contact volume NOTE 1
For practical reasons it is defined by the amount of agent in grams (g) present in the skin contaminant layer.
NOTE 2 The outcome of the process of dermal exposure, i.e. the contact, can be expressed by different parameters of exposure.
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2.7 dermal exposure surface skin surface area where an agent is present NOTE For practical reasons this is represented by a two dimensional representation of the skin contaminant layer in 2 square centimetres (cm ).
2.8 exposure period time the agent is present in the skin contaminant layer, i.e. contact time
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NOTE 1 The process by which an agent crosses an outer exposure surface of a target is called intake. In case of the concentration driven transport from the skin contaminant layer into the skin, i.e. crossing the (exposure surface) interface between skin contaminant layer and the stratum corneum as an absorption barrier, the process is called uptake. Therefore, relevant for uptake would be the time- exposure concentration profile for an identified area of the skin contaminant layer over a defined period of time. NOTE 2 Other relevant types of time intervals, e.g. sampling time (B-C), immission or loading time (A-D), and post emission time (D-E), are illustrated in Figure 1.
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time exposure loading exposure/contact time immission/loading time
D-E post immission time B-C sampling time
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Key X Y A-E A-D
Figure 1 — Different types of time intervals relevant in view of dermal exposure 2.9 immission transport of an agent from a defined source to the skin or outer clothing contaminant layer compartment
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CEN/TR 15278:2006 (E)
2.10 potential dermal exposure mass mass retrieved from (outer and inner clothing contaminant layer and exposure mass, i.e. mass retrieved from the covered and uncovered by clothing) parts of the skin contaminant layer compartment NOTE For practical reasons related to sampling methodology and strategy the term potential exposure mass has been introduced. It refers to the agent mass that has the potential the reach the skin (contaminant layer) since it has landed on the clothing and the agent mass that has actually reached the skin. The conceptual model distinguishes between outer and inner clothing contaminant layer compartment, respectively, and characterises the clothing itself as a buffer layer.
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2.11 skin contaminant layer compartment compartment on top of the stratum corneum of the human skin NOTE The skin contaminant layer compartment is formed by sebum lipids, sweat and additional water from transepidermal water loss, rest products from cornification and unshed corneocytes, and is given by its three dimensional volume.
2.12 workplace the defined area or areas in which the work activities are carried out
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[EN 1540:1998, 3.36]
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Assessment of dermal exposure
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3.1 General
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Sampling strategies provide general guidelines to approach dermal exposure issues systematically. This approach is according to the conceptual model illustrated in Figure A.1. The conceptual model structures the process of dermal exposure to chemicals and assists in evaluating the performance of sampling methods. Basically, the model systematically describes the transport of contaminant mass from the source onto the surface of the skin. Six compartments, i.e. three environmental compartments (air, surface and source) and three personal compartments (outer and inner clothing, and skin contaminant layer) and eight mass transport processes onwards and from the compartments are distinguished and their mutual relationship is outlined. 3.2 Objectives
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In general, five objectives for assessing dermal exposure can be distinguished: a)
evaluation of exposure processes and pathways
Evaluation of exposure processes and pathways is an important tool for selecting an adequate sampling strategy and for effective risk management. b)
evaluation of exposure control measures or interventions
Evaluation of control measures is relevant in view of effectiveness of exposure reduction and post-intervention surveillance. c)
risk assessment
Results for risk assessment purposes should be linked to results of hazard assessment. Hazardous agents that show local effects are distinguished from hazardous agents that show systemic health effects after uptake (see [3]). For the first group of agents, quantitative exposure assessment seems to be very difficult, however some data are available on effect and dosage and duration.
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